Evaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,349
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date
研究概览
简要总结
This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
- •First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
- •Patients do have >1 advanced therapy filled on index date
- •Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
- •Age 18+ years at index
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date
时间窗: During 12 months post-index date
Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.
Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date
时间窗: During 12 months post-index date
Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.
Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date
时间窗: During 12 months post index date
Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.
Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date
时间窗: During 12 months post index date
Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.
Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date
时间窗: During 12 months post-index date
Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.
次要结局
- Duration of Index Medication Persistent Therapy During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy(During 12 months post-index date)
- Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy(During 12 months post-index date)
- Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date(During 12 month post-index date)
- Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy(During 12 months post-index date)
- Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy(During 12 months post-index date)
- Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date(During 12 months pre-index date)
- Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date(During 12 months pre-index date)
- Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of All Cause Outpatient Visits During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date(During 12 months pre-index date)
- Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date(During 12 months pre-index date)
- Mean of All Cause Inpatient Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of All Cause Pharmacy Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date(During 12 months pre-index date)
- Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy(During 12 months post-index date)
- Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date(During 12 months post-index date)
- Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date(During 12 months pre-index date)
- Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date(During 12 months pre-index date)
- Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date(During 12 months pre-index date)
- Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date(During 12 months post-index date)
- Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date(During 12 months pre-index date)
- Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date(During 12 months post-index date)
- All Cause Total Health Care Cost During 12 Months Pre-index Date(During 12 months pre-index date)
- All Cause Total Health Care Cost During 12 Months Post-index Date(During 12 months post-index date)